Systematic Review on the Efficacy of Interventions for Fear of Childbirth, Anxiety and Fear in Pregnant Women


 Background: Fears and anxieties during pregnancy and childbirth are a frequent phenomenon and can have negative consequences on wellbeing, psychological health and birth outcomes. Therefore, it is important to focus on the interventions to reduce those fears and anxieties during pregnancy and childbirth. A systematic review was conducted to examine the current literature on psychological interventions to reduce anxieties and fears during pregnancy and childbirth. Scopus and PubMed were searched from 2015 up until December 2020 for relevant studies. Included were pregnant women, with no restriction on age ranges or parity. Entered in the review were quantitative studies, including randomized controlled trials (RCTs), non-randomized controlled trials as well as treatment evaluations. After reviewing titles, abstracts and studies, 72 studies were included in this review as they met the inclusion criteria. Standard methodological procedures for systematic reviews were used. The quality assessment of included articles was done by using the Quality Assessment Tool for Quantitative Studies (EPHPP). Results: The main results of this review concern the fear and anxiety reducing effects of psychoeducation, relaxation techniques, guided imagery, supportive care through a midwife, group discussion, “lifestyle based education”, writing therapy, cognitive behavioral therapy groups and stress intervention, individual structured psychotherapy, communication skills training, counseling approaches (except distraction techniques), a motivational interviewing psychotherapy, emotional freedom techniques, breathing awareness and different hypnotherapeutic techniques on different fears and anxieties during pregnancy and childbirth. For mindfulness-based interventions mixed results are found. The effect of an acceptance and commitment therapy, biofeedback interventions, a mind body intervention, mental health training courses, the group intervention Nyytti® as well as cognitive analytic therapy is unclear, due to weak ratings. Antenatal class attendance reduced delivery fear significantly only in first time mothers. An internet-based problem-solving treatment did not reduce anxiety during pregnancy. Conclusion: A broad range of interventions show positive effects on fear of childbirth and fear and anxiety in pregnancy. Further research should address other acknowledged psychotherapeutic practices, like psycho-dynamic as well as systemic interventions, as they are underrepresented within this review. Furthermore , there is a need for manualized therapeutic interventions, with regards to a combination of effective intervention components.


Background and objectives Background
In the current literature, the prevalence rate of high levels of fear of childbirth is stated as 36.7% in Ireland and in India the prevalence rate of severe pregnancy anxiety levels reached up to 22% (Madhavanprabhakaran et al., 2015;. Women with very high scores on Fear of Childbirth (FOC) or Tocophobia often suffer under longer birth processes and stronger to unbearable pain compared to women with less fear (Adams et al., 2012;Junge et al., 2018;Laursen et al., 2009;Nettelbladt et al., 1976;Reck et al., 2013;Striebich & Ayerle, 2020). FOC is reported as one of the most common reasons for unnecessary cesarean sections (Adams et al., 2012;Junge et al., 2018;Laursen et al., 2009;Nettelbladt et al., 1976;Reck et al., 2013;Striebich & Ayerle, 2020). Compared to women with low levels of FOC, women with intermediate or high levels of FOC seem to have more negative birth experiences (Elvander et al., 2013). FOC can not only have a negative impact on the birth process, but also influences the wellbeing during pregnancy (Slade et al., 2019).
A number of systematic reviews regarding interventions to treat fear of childbirth exist in the literature of the last five years. There are general systematic reviews and meta-analyses, that list different interventions and their effect on "fear of childbirth" (MoghaddamHosseini et al., 2018;Smith et al., 2019a;Striebich et al., 2018). Further systematic reviews focus on pregnancy specific anxiety (San Lazaro Campillo et al., 2017;Stoll et al., 2018), as well a mental disorders during pregnancy (van Ravesteyn et al., 2017).
The reviews of Bright et al. (2019), Brixval et al. (2014) and  are not listed as only study protocols were found. The mentioned reviews included studies up to the year 2019.
The present systematic literature review is the broadest and up to December 2020 most recent overview regarding the effects of psychological interventions on fear and anxiety related to pregnancy and childbirth published in the last five years with 72 included and rated studies.
While some of the past reviews focused only on certain outcome variables (e.g. only fear of childbirth as a narrow topic) (Moghaddam Hosseini et al., 2018;Smith et al., 2019b;Striebich et al., 2018), this present review focusses on broader fears and anxieties regarding the whole pregnancy and childbirth process and therefore addresses a research gap. Further previous studies examined studies until 2016, while this systematic review encloses studies up until December 2020.
The aim of this systematic review was to examine the effect of psychological interventions on "fear of childbirth" as well as fears and anxieties during pregnancy.
Previous reviews stated positive effects of psychological interventions. Hypnosis based, psychotherapeutic interventions and psychoeducation have a positive impact on fear of childbirth (Catsaros & Wendland, 2020;Stoll et al., 2018;Swift et al., in press). There is a need to keep those findings updated and an existing research gap to review further interventions stated within the literature. only intervention, and aroma therapy studies were excluded. Not included were medical studies, studies on pregnancy loss or sleeping problems, postpartum studies, traumatic birth studies, studies focusing on depression only, sport or physical activity interventions, studies relating to stillbirth, and ultrasound interventions. Studies written in other languages than German or English were also excluded.

Search methods for identification of studies
The electronic databases PubMed and Scopus were searched for articles using the terms "fear", "anxiety", "pregnancy", "childbirth", "intervention" from 2015 up to December 2020.
The initial search yielded a total of 3029 studies, after setting the time (year 2015-2020) and language filters a total of 2027 studies were displayed and a total of 1426 studies were screened for this review, after removing all duplicates. Further studies were excluded as they were either not relevant to the review or did not meet the inclusion criteria or were not found.

Data collection and analysis
One person was included in the data collection, management and analysis of the studies.
No software tools were used to support selection of studies. With an excel programme duplicates were analyzed. No standardized data collection forms were used. The data items are described in table 2.

Figure 1
Systematic Review Profile based on the prisma flow diagram (Moher et al., 2009)

Quality assessment and risk of bias in included studies
Of the 72 studies included, 22, 31 and 19, respectively, received a strong, moderate and weak rating on the "Quality Assessment Tool for Quantitative Studies" of the "Effective Public Health Practice Project (EPHPP)". The risk of bias in the included studies was assessed with this tool. One author was involved in the assessment of risk of bias in included studies. All studies (strong, moderate, weak ratings) were included in the analysis and interpretation. The ratings are listed in table 1.

Dealing with missing data
Few studies without access were excluded from analysis: Nasiri et al. (2018), Kao et al. (2017), Jahdi et al. (2016), Anton and David (2015), Soltani et al. (2017), Najafi et al. (2019), Hennelly et al. (2020. No authors or sponsors were contacted to obtain missing information or clarify the information available. Missing data (e.g. the period of time of data collection) within the viewed studies were marked as such in table 2.

CG: No intervention
The posttest PRAQ-R2 total mean scores (t=-4.095, p=.000) of the pregnant women in the IG and CG, as well as the subscales "fear of giving birth" (t=-3.275, p=.001) and "worries of bearing a physically or mentally handicapped child" (t=-4.354, p=.000) showed a statistically significant difference between the groups. The subscale "concerns about own appearance" did not show a statistical difference between the groups. When the intragroup comparisons of the pre-and posttest in the IG were examined, their "pretest prenatal distress", "fear of giving birth", "worries of bearing a physically or mentally handicapped child" and "pregnancy-related anxiety" total mean scores were significantly lower than their posttest mean scores (p<.05). In the CG only the "pretest fear of giving birth" subscale mean score was significantly lower than the posttest mean score (p<.05).
Pregnancy The results of the independent t-test showed no significant difference in the mean score of pre-intervention anxiety in the IG and CG (p=.287). According to AN-COVA with baseline score adjustment, the score of anxiety had a significant reduction in the IG compared to the CG (adjusted mean difference: -6.8; 95% confidence interval: -9.1 to -4.5; p<.001). The results of analysis of variance with repeated measures in assessing the changes in pregnancy anxiety score before, immediately after, and 1 month after the intervention showed that the length of time affects the anxiety score of pregnancy by decreasing it (p=.03) and that a significant difference was observed between the two groups in this regard (p=.001). After the intervention, the CG showed significant Postoperative SAS scores were significantly lower in the IG than in the CG and the differences were statistically significant (p < 0.01). In the CG, differences in anxiety and fear levels were not statistically significant between preoperation and postoperation (p > 0.05). The average state anxiety score in the educational software group and the educational booklet group was significantly lower than the CG (p<.001). Also, the mean state anxiety score in the educational software group was significantly decreased compared to the educational booklet group after the intervention (p<.001).

Beck anxiety inventory
The average score of trait anxiety in the educational software group and the educational booklet group was significantly lower than the control group (p<.001). Also, there was no significant difference between the two intervention groups ( The CAT + TAU group having lower (better) STAI scores at all four post-randomization assessment points than the TAU group.
For the four post-randomization repeated STAI measures, a simple summary measure for each individual patient, the average post-randomization score was calculated. Average post-randomization STAI scores were compared between the two arms (CAT and TAU), again with analyses unadjusted and adjusted for covariates. All the 95% CIs for the difference in mean followup scores between the CAT and TAU groups, include zero, which is compatible with no difference in outcomes between the randomized groups. There was a significant difference in the mean anxiety score between the IG and CG before the group educational counseling sessions. After this intervention, a significant reduction in the mean anxiety scores of intervened pregnant women compared to the control was found. This decrease in mean anxiety score after the In the IG, the mean scores of the PHQ-9 and GAD-7 before the intervention indicated mild symptoms of anxiety; these scores decreased significantly at the end of the intervention, indicating no symptoms (t=6.218, p<.001; t=5.422, p<.001, respectively). No changes in the PHQ-9 and GAD-7 scores were observed in women in the CG when scores before versus after intervention were compared.

Generalized Anxiety Disorder Scale (GAD-7)
General Anxiety during pregnancy

Primi-and multiparous
Postintervention scores of both PHQ-9 and GAD-7 were significantly lower in the IG than in the CG. Additionally, a larger proportion of women in the IG had no symptoms of anxiety after the IG compared with women in the CG.

CG: Waitlist condition
In both conditions anxiety and stress levels were reduced and well-being increased between pre-and post-test (T1-T2). In the HRV-biofeedback condition, within-group effect sizes were medium, and long-term improvements six weeks after the training (T1-T3) were similar to those at post-test for all outcome measures except depression. Statistically significant long-term improvements in the HRV-biofeedback condition were present for stress and psychological well-being. Effect sizes were larger in the HRV-biofeedback condition than in the waitlist condition on all outcome variables except anxiety.
When comparing the treatment effect between pregnant and non-pregnant women (the Condition-Pregnancy interaction), a statistically significant interaction effect for anxiety appeared. Additional analyses showed that HRV-biofeedback was more beneficial regarding anxiety reduction for pregnant women than for non-pregnant women ( tions in distress at post-assessment compared to CG (g(95%CI) = 0.88(0.34,1.43)), and moderate differences at follow-up, although these were not statistically significant (g(95%CI) = 0.52(-0.07,1.10)). The between group differences for anxiety severity were small and non-significant postassessment ( The mean (SD) state anxiety score in the IG decreased from before intervention to 4 weeks after counseling; the mean (SD) state anxiety score in the CG increased from before the intervention to 4 weeks after the completion of the counseling. No significant difference between the IG and CG before the intervention in terms of state anxiety score (p=.759). The mean state anxiety score in the IG was significantly lower than on the CG (adjusted mean difference: −7.8, CI 95% −4.5 to −11.1; p<.001) after intervention. The mean (SD) trait anxiety score in the IG decreased from before counseling to 4 weeks after counseling; the mean (SD) trait anxiety score in the IG was increased from before the intervention to 4 weeks after the completion of the counseling. There was no significant difference between the IG and CG before the intervention in terms of trait anxiety score (p=.473 In the pregnant women group and couples group, the average anxiety score of pregnant women after the intervention was significantly lower than before the intervention (p<.001). A significant difference was shown among the three groups after the intervention. After the intervention, the mean anxiety score of the pregnant women group was significantly lower than that of the CG (p=.002) and this score was significantly lower in the couples group than that in the pregnant women group (p=.045). The PWSQ score did not differ significantly between the 2 groups before the intervention (p >.05). After the intervention, the mean subscale scores were lower in the IG than in the CG and made a statistically significant post-intervention difference between the groups (p=.01). These scores suggest the effectiveness of the intervention in reducing pregnancy-specific stress. The mean score of state anxiety 8 weeks after intervention showed a statistically significant difference among the groups (p<.001). The mean state anxiety scores in the IG1 and IG2 were significantly reduced compared to the CG. The mean state anxiety score was also significantly reduced in the IG1 compared to the IG2. The mean post-intervention score of trait anxiety showed a statistically significant difference among the groups (p<.001). Compared to the CG, the mean trait anxiety score was significantly reduced in the IG1 and IG2; however, no significant difference was observed between the two intervention groups.  Some studies had "pregnancy related anxiety as an outcome" (Aksoy Derya et al., 2021;Bazrafshan et al., 2020;Goetz et al., 2020;Karamoozian & Askarizadeh, 2015;Khojasteh et al., 2016;Zarenejad et al., 2020) and others focused on "anxiety during pregnancy" (Akbarian et al., 2018;Alipour et al., 2020;Aslami et al., 2016;Beevi et al., 2016;Hajmohamadi et al., 2018;Heller et al., 2020;Mohammadi & Parandin, 2019;Montazeri et al., 2020;Sobhani et al., 2019;Sridhar et al., 2020;van der Zwan et al., 2019;Yazdanimehr et al., 2016;Zemestani, 2019).

Online vs. offline
Interventions were delivered in two forms: Via the internet respectively online or digital (Aksoy Derya et al., 2021;Fontein-Kuipers et al., 2016;Heller et al., 2020;Klabbers et al., 2019;Krusche et al., 2018;Larsson et al., in press;Loughnan, Sie, et al., 2019;Nieminen et al., 2016;Price et al., 2019;Rondung et al., 2018;Shahsavan et al., 2020;Yang et al., 2019) or offline respectively face to face. Online "mindfulness based interventions" seem to be effective online/digital (Goetz et al., 2020;Krusche et al., 2018;Price et al., 2019;Yang et al., 2019). For the offline "mindfulness-based interventions" results are inconsistent: Several studies find a positive effect (Sobhani et al., 2019;Warriner et al., 2018;Yazdanimehr et al., 2016;Zarenejad et al., 2020;Zemestani,  Fontein-Kuipers (2016) focused on identifying (potential) stress factors, problems or difficult situations in the past or present that may contribute to the development of maternal distress plus gave personal feedback regarding questionnaire results in a web-based tailored program. In the intervention group, the mean state anxiety and pregnancy anxiety scores were significantly lower at T2 compared to T1. The proportion of pregnancy anxiety scores above cut-off level were significantly lower at T2 compared to T1 and the state trait anxiety scores above cut-off level decreased, but this did not reach statistical significance.

Categories of interventions
Summarized within this review are educational interventions: psychoeducation (Bazrafshan et al., 2020;Boz et al., 2020;Hajmohamadi et al., 2018;Klabbers et  rating of the study from Haapio et al.(2017) does not seem to affect this result. One study examined the effect of partly psychoeducational, but mostly physiological education and only found a small effect of education on fear of childbirth (Swift et al., in press), while Rahmani et al. (2019) showed that peer education is effective in decreasing FOC in pregnant women.
With regards to relaxation trainings two studies show a positive effect of relaxation techniques like progressive muscle relaxation and relaxation training (Rajeswari & Sanjee-vaReddy, 2020;Toosi et al., 2017).
Four studies included in this review examined the effect of hypnotherapeutic interventions. Beevi et al. (2016) stated that an hypnotherapeutic intervention has a positive effect on reducing anxiety during pregnancy. Legrand et al. (2017) also found a positive effect on decreasing state anxiety and also showed a re-increase in the return-to-baseline phase, but this study has to be interpreted carefully, as only one person was examined and the rating of the study was weak. Waisblat et al. (2017) examined the effect of hypnotic communication on fear of women undergoing labor and found that hypnotic communication (communication that focusses on the awareness of the patient towards sensations and images that support relaxation and comfort) was more effective than standard communication. In addition fear of labor was significantly lower in a "philosophy of hypnobirthing" group compared to the control group (received routine care) (Uludağ & Mete, 2020). Boryri et al. (2018) and Khojasteh et al. (2016)  state/trait anxiety during pregnancy. There was a significant decrease in the level of state and trait anxiety in the GCBT group before and after the intervention. A study about a cognitive behavioral stress management intervention showed that this intervention significantly reduced the total anxiety (Karamoozian & Askarizadeh, 2015).
Also calming virtual reality environments seem to be effective on reducing anxiety during pregnancy, but this effect was mainly seen by qualitative data of the study (Sridhar et al., 2020). A motivational interviewing (MI) psychotherapy intervention showed a large and significant effect on the reduction of fear of childbirth (Abdollahi et al., 2020). Irmak Vural and Aslan  (2018) showed that after the intervention, the mean anxiety score of the pregnant women group was significantly lower than that of the control group and this score was significantly lower in the couples group than that in the pregnant women group. This result has to be interpreted carefully, due to a weak rating. Another study examined the group intervention Nyytti® (with psychoeducation elements, the lifespan model of motivation, practices to support mentalisation and mind-body connection) and showed a significant decrease of fear of childbirth, but has to be interpreted carefully due to weak ratings (Airo (Toivanen) et al., 2018). İsbir and Serçekus (2015) studied the effect of supportive care during labor by a midwife (physical, emotional, instructional, informational, advocacy support) and found that women supported by the midwifes showed significantly less fear on delivery. A "lifestyle based education" (included issues related to sleep, hygiene, nutrition, physical activity and exercise, self-concept and sexuality) found a significant and positive effect, in the direction of reducing state and trait anxiety during pregnancy (Sanaati et al., 2017). Kang et al. (2020) examined the effect of different psychological interventions (like psychological support, education, relaxation training, family support, music listening) on anxiety of pregnant women undergoing interventional prenatal diagnosis. The authors found that postoperative anxiety scores were significantly lower in the psychological intervention than in the control group (Kang, 2020), but the results have to be interpreted carefully due to weak ratings. A mind body intervention on the effect of FOC showed a significantly reducing effect on the level of anxiety and anxiety symptoms among antenatal women who were subjected to mind body intervention than those who were not (Mary et al., 2017), but this effect has to be interpreted carefully due to a weak rating. Another study focused on the effect of group discussion in combination with routine care with a significant decrease of state anxiety during pregnancy (Sheikh-Azadi et al., 2016). An acceptance and commitment therapy (ACT) intervention showed a positive effect on global distress, but must be interpreted carefully due to weak ratings. A cognitive analytic therapy did not show any difference in trait/state anxiety between the randomized groups, but this result has to be interpreted carefully due to a weak rating.

Summary of main findings
Contrary results were shown regarding biofeedback interventions, while one study found that FOC was significantly reduced through biofeedback, another study did not find significant long-term improvements, but those results have to be interpreted carefully due to weak rat- and group discussion together with routine care seem to be effective in reducing anxiety during pregnancy and childbirth. While an internet-based problem-solving treatment did not show positive effects on reducing anxiety during pregnancy and antenatal class attendance reduced delivery fear significantly in first time, but not multiparous mothers.

Comparison of reviews based on mindfulness-based interventions
Compared to earlier systematic reviews within the literature, there are on the one side conflicting on the other side similar results. The systematic review and meta-analysis of Dhillon et al. (2017) also found benefits of mindfulness based interventions in RCT and non-RCT studies on anxiety, while mixed results are shown for perceived stress. The pilot randomized trial of Beattie et al. (2017) in this present review did not find a beneficial effect of mindfulness based interventions on perceived stress.
The study of Hall et al. (2012) was not accessible for this review, as only the abstract ex- ists, but the results seem to show a non-significant trend of mindfulness training towards a decrease in anxiety, this stands in conflict with the results within this present study.
Conflicting results also exist in comparison with the study of Lever and Taylor (2016)  In the review of Riet et al. (2019) mixed results were found in three studies regarding between-group effects of mindfulness based interventions on anxiety. While two studies found a significant between-group effect in favor of the intervention group, one did not, but showed a significant decrease of anxiety due to mindfulness in the intervention group (Riet et al., 2019).
In the present study the between-group effect of mindfulness in moderate to strong RCTs on the outcome anxiety is significant and finds similar results compared to Riet et al. (2019).
In the study of Shi and MacBeth (2017) seven RCTs showed significant reductions on anxiety due to mindfulness based interventions compared with control groups and four of five non-controlled studies also showed a significant decrease of anxiety. The RCT results within this present review with anxiety as an outcome seem to match with this result.

Comparison of reviews based on hypnotherapeutic interventions
Two systematic reviews examined the effect of hypnosis based interventions and found a positive impact of hypnosis-based interventions on childbirth experience (Catsaros & Wendland, 2020;MoghaddamHosseini et al., 2018;Smith et al., 2019a). This finding fits the positive effect of hypnosis-based interventions found in the present study on anxiety and fear.

Comparison of reviews based on different therapeutic techniques/schools
Three reviews focussed on psychotherapy interventions (Li et al., 2020;Ponting et al., 2020;Sockol, 2018). Li et al. (2020) examined the effect of interpersonal psychotherapy (IPT) on fears and anxieties and found that interpersonal psychotherapy and peer supported interpersonal psychotherapy reduces fears and anxieties during pregnancy and childbirth. Sockol et al. (2018) found similar effects of IPT on anxiety and fears in perinatal women. Contrary to this outcome, the review of Ponting (2020) could not confirm this positive effect of IPT. No study within this review focussed on interpersonal psychotherapy.
Regarding cognitive behavioral therapy (studied was the general CBT, not mindfulness based), the systematic review of Li et al. (2020) found mixed effects. While one study did not find a significant between-group effect (Loughnan, Joubert, et al., 2019), other studies found a significant reduction of fear and anxiety during pregnancy and childbirth (Li et al., 2020). Based on the studies of the review of Li et al. (2020), Striebich et al. (2018) and the present study, mixed results for CBT are shown, but when taking the ratings of these studies into account, CBT seems to be effective in reducing fears and anxieties during pregnancy and childbirth.

Comparison of reviews based on writing therapy
Within this present systematic review, Montazeri et al. (2020) showed a significant and reductional effect of writing therapy sessions on anxiety during pregnancy, which opposes the result of the meta-analysis from Quian et al. (2020), which did not find a significant reducing effect of expressive writing therapy on anxiety.

Comparison with reviews based on e-health and technology-based interventions
The systematic review and meta-analysis of Bayrampour et al. (2019) showed a significant reduction of anxiety scores in the e-health compared to a control group. Another systematic review and meta-analysis showed mixed results for the effect of online cognitive behavioral therapy (Loughnan, Joubert, et al., 2019). Mixed results about internet based cognitive behavioral therapy are also found within the present systematic review. For e-health interventions and their effect on reducing anxiety and fear regarding pregnancy and childbirth, mixed results are found within the present study and earlier systematic reviews and meta-analyses.

Limitations and Strenghts
Limitations of the present systematic review are differences in the conceptualisations and operationalisations of prenatal anxiety and anxiety and fear during childbirth. Most of the studies are from Iran, so the results could be biased due to cultural background. Also the present review only included studies written in English and German. Another limitation is, that only one person rated the EPHPP criteria. The settings and duration of interventions differed between the studies and this fact could bias the results.
One strength is, that the present study includes the largest number of studies yet known in systematic reviews addressing similar topics.

Study Implications
The present review only focused on certain therapeutic schools and psychotherapeutic interventions based on cognitive behavioral therapies are overrepresented, while there is only one psychoanalytic study and no study on systemic therapy. Furthermore, there is a need for manualized therapeutic interventions, with regards to a combination of effective intervention components.

Conclusion
Within this systematic review, a wide range of psychological interventions are shown to be effective in reducing fears and anxieties during pregnancy and childbirth. These results are partly consistent with earlier systematic reviews and meta-analyses. Further research should address other acknowledged psychotherapeutic practices, like psychoanalytic or psychodynamic as well as systemic interventions, as they are underrepresented within this review. Furthermore, there is a need for manualized therapeutic interventions, with regards to a combination of effective intervention components.